Dimethomorph; Pesticide Tolerance, 76173-76177 [E6-21499]
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Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Rules and Regulations
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and bound), in or on hop, dried cones
at 10 ppm; soybean, seed at 0.25 ppm;
soybean, forage at 3.5 ppm; soybean,
hay at 15 ppm; grain, aspirated fractions
at 35 ppm; and soybean, refined oil at
0.40 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this rule has
been exempted from review under
Executive Order 12866 due to its lack of
significance, this rule is not subject to
Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any
enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104–4). Nor does it require any
special considerations under Executive
Order 12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994); or OMB review or any Agency
action under Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are
established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the
Agency has determined that this action
will not have a substantial direct effect
on States, on the relationship between
the national government and the States,
or on the distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
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Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is
defined in the Executive order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this rule
does not have any ‘‘tribal implications’’
as described in Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’ ‘‘Policies that have tribal
implications’’ is defined in the
Executive order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
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the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of this final
rule in the Federal Register. This final
rule is not a ‘‘major rule’’ as defined by
5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: December 8, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.443 is amended:
a. In paragraph (a), in the table, by
alphabetically adding commodities to
read as set forth below; and
I b. In paragraph (b), in the table, by
removing the commodities ‘‘Hop, dried
cone’’ and ‘‘Soybean’’.
I
I
§ 180.443
residues.
Myclobutanil; tolerances for
(a) * * *
Parts per
million
Commodity
*
*
*
Grain, aspirated fractions .........
*
*
*
Hop, dried cones ......................
*
*
*
Soybean, forage .......................
Soybean, hay ............................
Soybean, refined oil ..................
Soybean, seed ..........................
*
*
*
*
*
*
*
*
35
*
10
*
3.5
15
0.40
0.25
*
[FR Doc. E6–21489 Filed 12–19–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2005–0532; FRL–8104–6]
Dimethomorph; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes a
tolerance for residues of the fungicide,
dimethomorph, (E,Z) 4-[3-(4-
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chlorophenyl)-3-(3,4-dimethoxyphenyl)1-oxo-2-propenyl] morpholine in or on
brassica, head and stem, subgroup 5A.
The Interregional Research Project No. 4
(IR–4), 500 College Road East, Suite 201
W, Princeton, NJ 08540 requested this
tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA), as amended
by the Food Quality Protection Act of
1996 (FQPA).
DATES: This regulation is effective
December 20, 2006. Objections and
requests for hearings must be received
on or before February 20, 2007, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2005–0532. All documents in the
docket are listed in the index for the
docket. Although listed in the index,
some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is
open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The Docket telephone number
is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460-0001; telephone number:
(703) 305–7610; e-mail address:
jackson.sidney@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
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A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS 111), e.g.,
agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
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• Animal production (NAICS 112),
e.g., cattle ranchers and farmers, dairy
cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311),
e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of the FFDCA, as
amended by the FQPA, any person may
file an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2005–0532 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before February 20, 2007.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
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contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2005–0532, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket telephone number is (703) 305–
5805.
II. Background and Statutory Findings
In the Federal Register of March 10,
2006 (71 FR 12356) (FRL–7761–6), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 4E6848) by IR–4,
500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition
requested that 40 CFR 180.493 be
amended by establishing a tolerance for
residues of the fungicide,
dimethomorph, (E,Z) 4-[3-(4chlorophenyl)-3-(3,4-dimethoxyphenyl)1-oxo-2-propenyl] morpholine in or on
Brassica head and stem (Subgroup 5A)
at 2.0 parts per million (ppm). That
notice included a summary of the
petition prepared by BASF, the
registrant. There were no comments
received in response to the notice of
filing.
Supporting documents including the
Agency’s Human Health Risk
Assessment of dimethomorph and other
documents are available at
www.regulations.gov under the index of
the docket for this action, docket ID
number EPA–HQ–OPP–2005–0537.
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
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pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue....’’
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. For
further discussion of the regulatory
requirements of section 408 of the
FFDCA and a complete description of
the risk assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and
Determination of Safety
Consistent with section 408(b)(2)(D)
of FFDCA, EPA has reviewed the
available scientific data and other
relevant information in support of this
action. EPA has sufficient data to assess
the hazards of and to make a
determination on aggregate exposure,
consistent with section 408(b)(2) of
FFDCA, for a tolerance for residues of
dimethomorph on brassica, head and
stem, subgroup 5A food commodities at
2.0 ppm. EPA’s assessment of exposures
and risks associated with establishing
the tolerance follows.
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A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the toxic effects caused by
dimethomorph as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found at www.regulations.gov
under docket ID number EPA–HQ–
OPP–2005–0532; entitled, ‘‘Amended:
Dimethomorph: Human Health Risk
Assessment for Proposed Uses on
Brassica Stem and Head Subgroup 5A’’,
dated November 15, 2006.
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B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the NOAEL from the toxicology
study identified as appropriate for use
in risk assessment is used to estimate
the toxicological level of concern (LOC).
However, the LOAEL is sometimes used
for risk assessment if no NOAEL was
achieved in the toxicology study
selected. An uncertainty factor (UF) is
applied to reflect uncertainties inherent
in the extrapolation from laboratory
animal data to humans and in the
variations in sensitivity among members
of the human population as well as
other unknowns.
The linear default risk methodology
(Q*) is the primary method currently
used by the Agency to quantify nonthreshold hazards such as cancer. The
Q* approach assumes that any amount
of exposure will lead to some degree of
cancer risk, estimates risk in terms of
the probability of occurrence of
additional cancer cases. More
information can be found on the general
principles EPA uses in risk
characterization at https://www.epa.gov/
pesticides/health/human.htm.
A summary of the toxicological
endpoints for dimethomorph used for
human risk assessment can be found at
www.regulation.gov under docket ID
number EPA–HQ–OPP–2005–0532,
entitled, ‘‘Amended: Dimethomorph:
Human Health Risk Assessment for
Proposed Uses on Brassica Stem and
Head Subgroup 5A’’, dated November
15, 2006.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have been
established (40 CFR 180.493) for the
residues of dimethomorph, in or on a
variety of raw agricultural commodities
including: Brassica, leafy greens,
subgroup 5B; lettuce, head; lettuce, leaf;
potato, wet peel; taro, corm; taro, leaves;
vegetable, bulb, group 3; vegetable,
cucurbit, group 9; and vegetable,
fruiting, group 8. Risk assessments were
conducted by EPA to assess dietary
exposures from dimethomorph in food
as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1-day or single
exposure.
No such effects were identified in the
toxicological studies for dimethomorph.
A quantitative acute dietary exposure
and risk assessment was therefore not
conducted for dimethomorph. No acute
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risk is expected from exposure to
dimethomorph.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the Dietary Exposure
Evaluation Model software with the
Food Commodity Intake Database
(DEEM-FCIDTM), which incorporates
food consumption data as reported by
respondents in the USDA 1994-1996
and 1998 Nationwide Continuing
Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to
the chemical for each commodity. In
conducting a Tier 1 chronic dietary risk
assessment, the Agency made the
following conservative assumptions:
a. All commodities having
dimethomorph tolerances contain
residues at the level of the tolerance,
and
b. Treatment of 100% of all registered
and proposed crops.
iii. Cancer. EPA has classified
dimethomorph ‘‘not likely’’ to be human
carcinogen. Therefore, a quantitative
cancer dietary exposure and risk
assessment was not performed.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring exposure data to complete a
comprehensive dietary exposure
analysis and risk assessment for
dimethomorph in drinking water.
Because the Agency does not have
comprehensive monitoring data,
drinking water concentration estimates
are made by reliance on simulation or
modeling taking into account data on
the physical characteristics of
dimethomorph. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.
Acute and chronic estimated drinking
water concentrations (EDWCs) of
dimethomorph in surface water were
calculated using Generic Estimated
Environmental Concentration (GENEEC)
Model. Drinking water residues were
then incorporated into the DEEMFCID(TM) into the food categories
‘‘water, direct, all sources’’ and ‘‘water,
indirect, all sources.’’
Based on the Tier 1 GENEEC and
Surface Water and Screening
Concentrations in Ground Water (SCIGROW) models, the EDWCs of
dimethomorph for chronic exposures
are 28.5 parts per billion (ppb) for
surface water and 0.30 ppb for ground
water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
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indoor pest control, termiticides, and
flea and tick control on pets).
Dimethomorph is not registered for
use on any sites that would result in
residential exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of the FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
dimethomorph and any other
substances and dimethomorph does not
appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has not assumed that
dimethomorph has a common
mechanism of toxicity with other
substances. For information regarding
EPA’s efforts to determine which
chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see the policy statements released by
EPA’s Office of Pesticide Programs
concerning common mechanism
determinations and procedures for
cumulating effects from substances
found to have a common mechanism on
EPA’s website at https://www.epa.gov/
pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408 of FFDCA
provides that EPA shall apply an
additional tenfold margin of safety for
infants and children in the case of
threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. Margins of safety are
incorporated into EPA risk assessments
either directly through use of a margin
of exposure analysis or through using
uncertainty (safety) factors in
calculating a dose level that poses no
appreciable risk to humans. In applying
this provision, EPA either retains the
default value of 10X when reliable data
do not support the choice of a different
factor, or, if reliable data are available,
EPA uses a different additional safety
factor value based on the use of
traditional uncertainty factors and/or
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special FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity.
The toxicology data on dimethomorph
provide no indication of enhanced
sensitivity of infants and children based
on the results from developmental
studies conducted with rats and rabbits
as well as a 2-generation reproduction
study conducted with rats. There were
no toxic effects observed in either the
rat developmental toxicity or the rat 2generation reproductive toxicity studies
that were lower than doses which
produced toxic effects in the parents. No
developmental toxicity was
demonstrated in the rabbit
developmental toxicity study. The
developmental and reproductive
toxicity data did not indicate increased
susceptibility of rats or rabbits to in
utero and/or postnatal exposure.
3. Conclusion. EPA has determined
that reliable data show that it would be
safe for infants and children to reduce
the FQPA safety factor to 1X. That
decision is based on the following
findings:
i. The toxicity database for
dimethomorph is complete.
ii. There is no evidence that
dimethomorph results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2-generation
reproduction study.
iii. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100% crop
treated (CT) and tolerance-level
residues. Conservative ground water
and surface water modeling estimates
were used.
Residential exposure to
dimethomorph is not expected since
there are no currently registered
residential uses for the pesticide.
E. Aggregate Risks and Determination of
Safety
In examining aggregate risk, the
Agency takes into account all available
reliable information concerning
exposures from pesticide residues in
food and other exposures including
drinking water and potential residential
exposure to pesticides from such uses as
lawn care applications (turf), golf course
and others. Aggregate risk assessment
considerations must also include
potential exposures from oral, dermal
and inhalation routes.
1. Acute risk. No acute dietary toxicity
endpoints were identified; no acute risk
is expected from exposure to
dimethomorph.
2. Chronic risk. Using the exposure
assumptions described in this unit for
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chronic exposure, EPA has concluded
that exposure to dimethomorph from
food + water will utilize 8.6% of the
chronic population adjusted dose
(cPAD) for the U.S. population, 7.0% of
the cPAD for all infants < 1 year, and
19.9% of the cPAD for children -2 years.
There are no residential uses for
dimethomorph that result in chronic
residential exposure. Risk estimates for
all population subgroups are below the
Agency’s LOC (do not exceed 100% of
the cPAD).
3. Short-term risk. Short-term
aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Dimethomorph is not registered for
use on any sites that would result in
residential exposure. Therefore, a shorttern aggregate risk assessment is not
required. The aggregate risk is the sum
of the risk from food and water, which
do not exceed the Agency’s LOC.
4. Intermediate-term risk
Intermediate-term aggregate exposure
takes into account residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level).
Dimethomorph is not registered for
use on any sites that would result in
residential exposure. Therefore, an
intermediate-term risk assessment is not
required. The aggregate risk is the sum
of the risk from food and water, which
do not exceed the Agency’s LOC.
5. Aggregate cancer risk for U.S.
population. Dimethomorph has been
classified as a Group E carcinogen
showing no evidence of human
carcinogenicity. This classification was
based upon lack of evidence of
carcinogenicity in rat and mice studies.
The Agency concludes that the
pesticidal uses of dimethomorph are not
likely to pose a cancer risk to humans.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, and to infants and children
from aggregate exposure to
dimethomorph residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
A reliable method for the
determination of dimethomorph
residues in brassica, head and stem
subgroup 5A exist; this method is the
Food and Drug Administration (FDA)
Multi-Residue Method, Protocol D, as
published in the Pesticide Analytical
Manual I. In addition, the method may
be requested from: Chief, Analytical
Chemistry Branch, Environmental
E:\FR\FM\20DER1.SGM
20DER1
76177
Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Rules and Regulations
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no established or proposed
Codex, Canadian or Mexican maximum
residue limits or tolerance for
dimethomorph in or on brassica, head
and stem, subgroup 5A.
V. Conclusion
Therefore, the tolerance is established
for residues of dimethomorph, (E,Z) 4[3-(4-chlorophenyl)-3-(3,4dimethoxyphenyl)-1-oxo-2-propenyl]
morpholine in or on brassica, head and
stem, subgroup 5A at 2.0 ppm.
rwilkins on PROD1PC63 with RULES
VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this rule has
been exempted from review under
Executive Order 12866 due to its lack of
significance, this rule is not subject to
Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any
enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104–4). Nor does it require any
special considerations under Executive
Order 12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994); or OMB review or any Agency
action under Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note). Since
VerDate Aug<31>2005
17:07 Dec 19, 2006
Jkt 211001
tolerances and exemptions that are
established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the
Agency has determined that this action
will not have a substantial direct effect
on States, on the relationship between
the national government and the States,
or on the distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is
defined in the Executive order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this rule
does not have any ‘‘tribal implications’’
as described in Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’ ‘‘Policies that have tribal
implications’’ is defined in the
Executive order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
PO 00000
Frm 00067
Fmt 4700
Sfmt 4700
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of this final
rule in the Federal Register. This final
rule is not a ‘‘major rule’’ as defined by
5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: December 8, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.493 is amended by
alphabetically adding a commodity to
the table in paragraph (a) to read as
follows:
I
§ 180.493 Dimethomorph; tolerance for
residues.
(a) * * *
Commodity
Parts per million
*
*
*
Brassica, head and stem,
subgroup 5A ................
*
*
*
*
*
*
*
*
*
*
2.0
*
*
[FR Doc. E6–21499 Filed 12–19–06; 8:45 am]
BILLING CODE 6560–50–S
E:\FR\FM\20DER1.SGM
20DER1
Agencies
[Federal Register Volume 71, Number 244 (Wednesday, December 20, 2006)]
[Rules and Regulations]
[Pages 76173-76177]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-21499]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0532; FRL-8104-6]
Dimethomorph; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of the
fungicide, dimethomorph, (E,Z) 4-[3-(4-
[[Page 76174]]
chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl] morpholine in
or on brassica, head and stem, subgroup 5A. The Interregional Research
Project No. 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ
08540 requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of
1996 (FQPA).
DATES: This regulation is effective December 20, 2006. Objections and
requests for hearings must be received on or before February 20, 2007,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0532. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at https://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7610; e-mail address: jackson.sidney@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2005-0532 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before February 20, 2007.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2005-0532, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of March 10, 2006 (71 FR 12356) (FRL-7761-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
4E6848) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ
08540. The petition requested that 40 CFR 180.493 be amended by
establishing a tolerance for residues of the fungicide, dimethomorph,
(E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl]
morpholine in or on Brassica head and stem (Subgroup 5A) at 2.0 parts
per million (ppm). That notice included a summary of the petition
prepared by BASF, the registrant. There were no comments received in
response to the notice of filing.
Supporting documents including the Agency's Human Health Risk
Assessment of dimethomorph and other documents are available at
www.regulations.gov under the index of the docket for this action,
docket ID number EPA-HQ-OPP-2005-0537.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the
[[Page 76175]]
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C) of
FFDCA requires EPA to give special consideration to exposure of infants
and children to the pesticide chemical residue in establishing a
tolerance and to ``ensure that there is a reasonable certainty that no
harm will result to infants and children from aggregate exposure to the
pesticide chemical residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see https://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of dimethomorph on
brassica, head and stem, subgroup 5A food commodities at 2.0 ppm. EPA's
assessment of exposures and risks associated with establishing the
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by dimethomorph as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at
www.regulations.gov under docket ID number EPA-HQ-OPP-2005-0532;
entitled, ``Amended: Dimethomorph: Human Health Risk Assessment for
Proposed Uses on Brassica Stem and Head Subgroup 5A'', dated November
15, 2006.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the NOAEL from the toxicology study identified as
appropriate for use in risk assessment is used to estimate the
toxicological level of concern (LOC). However, the LOAEL is sometimes
used for risk assessment if no NOAEL was achieved in the toxicology
study selected. An uncertainty factor (UF) is applied to reflect
uncertainties inherent in the extrapolation from laboratory animal data
to humans and in the variations in sensitivity among members of the
human population as well as other unknowns.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at https://www.epa.gov/pesticides/health/human.htm.
A summary of the toxicological endpoints for dimethomorph used for
human risk assessment can be found at www.regulation.gov under docket
ID number EPA-HQ-OPP-2005-0532, entitled, ``Amended: Dimethomorph:
Human Health Risk Assessment for Proposed Uses on Brassica Stem and
Head Subgroup 5A'', dated November 15, 2006.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.493) for the residues of dimethomorph, in or on
a variety of raw agricultural commodities including: Brassica, leafy
greens, subgroup 5B; lettuce, head; lettuce, leaf; potato, wet peel;
taro, corm; taro, leaves; vegetable, bulb, group 3; vegetable,
cucurbit, group 9; and vegetable, fruiting, group 8. Risk assessments
were conducted by EPA to assess dietary exposures from dimethomorph in
food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
No such effects were identified in the toxicological studies for
dimethomorph. A quantitative acute dietary exposure and risk assessment
was therefore not conducted for dimethomorph. No acute risk is expected
from exposure to dimethomorph.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates
food consumption data as reported by respondents in the USDA 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to the chemical for each commodity.
In conducting a Tier 1 chronic dietary risk assessment, the Agency made
the following conservative assumptions:
a. All commodities having dimethomorph tolerances contain residues
at the level of the tolerance, and
b. Treatment of 100% of all registered and proposed crops.
iii. Cancer. EPA has classified dimethomorph ``not likely'' to be
human carcinogen. Therefore, a quantitative cancer dietary exposure and
risk assessment was not performed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for dimethomorph in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of dimethomorph. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.
Acute and chronic estimated drinking water concentrations (EDWCs)
of dimethomorph in surface water were calculated using Generic
Estimated Environmental Concentration (GENEEC) Model. Drinking water
residues were then incorporated into the DEEM-FCID(\TM\) into the food
categories ``water, direct, all sources'' and ``water, indirect, all
sources.''
Based on the Tier 1 GENEEC and Surface Water and Screening
Concentrations in Ground Water (SCI-GROW) models, the EDWCs of
dimethomorph for chronic exposures are 28.5 parts per billion (ppb) for
surface water and 0.30 ppb for ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control,
[[Page 76176]]
indoor pest control, termiticides, and flea and tick control on pets).
Dimethomorph is not registered for use on any sites that would
result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to dimethomorph and any other
substances and dimethomorph does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that dimethomorph has
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at https://www.epa.gov/pesticides/
cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
margin of exposure analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. In applying this provision, EPA either retains the default
value of 10X when reliable data do not support the choice of a
different factor, or, if reliable data are available, EPA uses a
different additional safety factor value based on the use of
traditional uncertainty factors and/or special FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity. The toxicology data on
dimethomorph provide no indication of enhanced sensitivity of infants
and children based on the results from developmental studies conducted
with rats and rabbits as well as a 2-generation reproduction study
conducted with rats. There were no toxic effects observed in either the
rat developmental toxicity or the rat 2-generation reproductive
toxicity studies that were lower than doses which produced toxic
effects in the parents. No developmental toxicity was demonstrated in
the rabbit developmental toxicity study. The developmental and
reproductive toxicity data did not indicate increased susceptibility of
rats or rabbits to in utero and/or postnatal exposure.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
i. The toxicity database for dimethomorph is complete.
ii. There is no evidence that dimethomorph results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iii. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% crop treated (CT) and tolerance-level residues. Conservative
ground water and surface water modeling estimates were used.
Residential exposure to dimethomorph is not expected since there
are no currently registered residential uses for the pesticide.
E. Aggregate Risks and Determination of Safety
In examining aggregate risk, the Agency takes into account all
available reliable information concerning exposures from pesticide
residues in food and other exposures including drinking water and
potential residential exposure to pesticides from such uses as lawn
care applications (turf), golf course and others. Aggregate risk
assessment considerations must also include potential exposures from
oral, dermal and inhalation routes.
1. Acute risk. No acute dietary toxicity endpoints were identified;
no acute risk is expected from exposure to dimethomorph.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
dimethomorph from food + water will utilize 8.6% of the chronic
population adjusted dose (cPAD) for the U.S. population, 7.0% of the
cPAD for all infants < 1 year, and 19.9% of the cPAD for children -2
years. There are no residential uses for dimethomorph that result in
chronic residential exposure. Risk estimates for all population
subgroups are below the Agency's LOC (do not exceed 100% of the cPAD).
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Dimethomorph is not registered for use on any sites that would
result in residential exposure. Therefore, a short-tern aggregate risk
assessment is not required. The aggregate risk is the sum of the risk
from food and water, which do not exceed the Agency's LOC.
4. Intermediate-term risk Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Dimethomorph is not registered for use on any sites that would
result in residential exposure. Therefore, an intermediate-term risk
assessment is not required. The aggregate risk is the sum of the risk
from food and water, which do not exceed the Agency's LOC.
5. Aggregate cancer risk for U.S. population. Dimethomorph has been
classified as a Group E carcinogen showing no evidence of human
carcinogenicity. This classification was based upon lack of evidence of
carcinogenicity in rat and mice studies. The Agency concludes that the
pesticidal uses of dimethomorph are not likely to pose a cancer risk to
humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to dimethomorph residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
A reliable method for the determination of dimethomorph residues in
brassica, head and stem subgroup 5A exist; this method is the Food and
Drug Administration (FDA) Multi-Residue Method, Protocol D, as
published in the Pesticide Analytical Manual I. In addition, the method
may be requested from: Chief, Analytical Chemistry Branch,
Environmental
[[Page 76177]]
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
B. International Residue Limits
There are no established or proposed Codex, Canadian or Mexican
maximum residue limits or tolerance for dimethomorph in or on brassica,
head and stem, subgroup 5A.
V. Conclusion
Therefore, the tolerance is established for residues of
dimethomorph, (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-
oxo-2-propenyl] morpholine in or on brassica, head and stem, subgroup
5A at 2.0 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: December 8, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.493 is amended by alphabetically adding a commodity to
the table in paragraph (a) to read as follows:
Sec. 180.493 Dimethomorph; tolerance for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Brassica, head and stem, subgroup 5A................. 2.0
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E6-21499 Filed 12-19-06; 8:45 am]
BILLING CODE 6560-50-S